Companies Note Collaborations, Financing and Clinical Trial Success

With the holiday break upon us, many companies in the pharma and biotech industry have made some important announcements – some big, some small. BioSpace has gathered a number of announcements that might have gone unnoticed and put them together below.

Annexon Biosciences – South San Francisco-based Annexon Biosciences secured $75 million in a Series C financing round. The funds will be used to support development of the company’s lead program NX005, a monoclonal antibody drug candidate designed for treatment in autoimmune and neurodegenerative diseases. Also, the funds will support development of ANX007 IVT, an antigen-binding fragment (Fab) drug candidate designed for use in ophthalmic settings, which is currently in Phase Ib proof-of-principle studies expected to read out in 2019.

The Series C financing round was led by new investor Bain Capital Life Sciences, with participation by Surveyor Capital (a Citadel company), and Adage Capital Partners. Existing investors, including NEA, Blackstone Life Sciences, Novartis Venture Fund and Satter Investment Management, also participated in the round.

Annexon Chief Executive Officer Doug Love said the financing will fund the company’s lead programs through several clinical stages. The funds will also support the rapid advancement of our next generation drug candidates in autoimmune and neurodegenerative settings, he said.

Chugai Pharmaceutical Co. – Japan-based Chugai said its Phase III monotherapy study of satralizumab hit its primary endpoints in a Phase III study. Satralizumab is being investigated for the treatment of neuromyelitis optica spectrum disorder (NMOSD), which currently has no approved treatments. The study showed that patients treated with satralizumab achieved a statistically significant reduction in the risk of disease relapse in comparison to placebo. The safety profile of satralizumab was consistent with that seen in previous studies. Further details will be presented at a future medical meeting, the company said. Following the positive Phase III results, Chugai CEO Yasushi Ito said the company plans to file for regulatory approval of satralizumab as a monotherapy.

Amgen and Molecular Partners – Pharma giant Amgen forged a collaborative deal with Switzerland-based Molecular Partners for the clinical development and commercialization of cancer drug MP0310. According to the release, MP0310 is a preclinical molecule designed to locally activate immune cells in the tumor by binding to FAP on tumor stromal cells and co-stimulating T cells via 4-1BB, an immune modulator.

The collaborative deal with worth up to about $500 million. Molecular Partners will receive an upfront payment of $50 million. The two companies will share the clinical development costs in defined percentages for the first three indications subject to certain conditions. For all additional clinical trials, Amgen is responsible for all development costs.

Patrick Amstutz, CEO of Molecular Partners, said MP0310 is the first candidate out of our portfolio of localized and multi-specific immune-cell agonists. The collaboration will allow the company to test multiple combinations of the asset with other agents, which leverages the potential of MP0310, he said.

Gilead has exclusive options to license worldwide rights to product candidates that emerge from three Scholar Rock TGFβ programs. The programs include inhibitors that target activation of latent TGFβ1 with high affinity and specificity, inhibitors that selectively target activation of latent TGFβ1 localized to extracellular matrix, and a third TGFβ discovery program. As part of the deal, Scholar Rock is responsible for antibody discovery and preclinical research through product candidate nomination and Gilead will be responsible for the program’s preclinical and clinical development and commercialization.

Under terms of the deal, Gilead will pay Scholar Rock $80 million upfront, $50 million of which will be in cash and $30 million in the purchase of common stock. In addition, Scholar Rock will receive a one-time milestone payment of $25 million upon the successful completion of specific preclinical studies. Depending on the outcome of the three programs, Scholar Rock could earn up to $1.425 billion in additional payments and also be eligible for sales royalties.